In a significant milestone for medical technology and Latin American entrepreneurship, the U.S. National Institutes of Health (NIH) has awarded approximately $469,388 to Samay, a health-tech company founded by Colombian physician Dr. María Artunduaga. This capital infusion, channeled through the National Heart, Lung, and Blood Institute (NHLBI) under the Small Business Innovation Research (SBIR) program, is earmarked for the rigorous validation of "Sylvee," a pioneering acoustic sensor designed to detect air trapping in the lungs—a hallmark of Chronic Obstructive Pulmonary Disease (COPD).
This development represents more than just a financial grant; it is an external validation of a multi-year effort to modernize how respiratory diseases are diagnosed and monitored. By moving away from traditional, often cumbersome diagnostic methods, Samay aims to bring agility and precision to a field that has historically relied on patients’ ability to perform strenuous breathing tests.
The Problem: Closing the Diagnostic Gap in COPD
COPD is a progressive, debilitating respiratory condition that severely limits lung capacity. Globally, it remains one of the leading causes of morbidity and mortality. A primary challenge in clinical practice is the disease’s "silent" nature in its early stages; often, by the time a patient seeks medical intervention due to persistent shortness of breath, the damage is already advanced.
Traditional diagnostics rely heavily on spirometry, a test that requires patients to inhale deeply and exhale forcefully into a tube. While effective for trained, healthy individuals, spirometry is difficult to perform for the elderly, children, or those experiencing an acute respiratory crisis. Furthermore, spirometry often fails to capture subtle internal lung alterations, such as air trapping, which are critical indicators of disease progression.
Sylvee addresses this by utilizing advanced acoustic sensors. Placed on the right side of the thorax, the device emits a controlled sound wave toward the lungs and analyzes the resonance. By interpreting how sound travels through the pulmonary tissue, the device can pinpoint pockets of trapped air that are otherwise invisible to standard tests. The procedure takes less than five minutes and requires no strenuous respiratory effort from the patient, potentially transforming how primary care physicians screen for the disease.
Chronology: A Journey from Personal Tragedy to Global Innovation
The inception of Sylvee is deeply rooted in the personal history of its founder. Dr. María Artunduaga, a physician who initially pursued a career in plastic surgery in the United States, underwent a profound professional pivot following the death of her grandmother, Sylvia. The elder woman passed away due to complications from an exacerbated case of COPD—a tragedy that, according to Dr. Artunduaga, could have been avoided with earlier detection and consistent monitoring.
Driven by this experience, Dr. Artunduaga transitioned into public health, bioengineering, and business, merging her medical expertise with a drive for technological disruption. The name "Sylvee" serves as a tribute to her grandmother, symbolizing the human element behind the data.
Key Milestones:
- The Foundational Years: Dr. Artunduaga builds the initial research framework, transitioning from clinical medicine to health-tech innovation.
- 2024: Samay secures the prestigious "MedTech Innovator" Grand Prize, becoming the first Latin American company to achieve this distinction, signaling to the global market that the startup is a serious player in the medical device sector.
- 2026 (September): The NIH awards $469,388 in research funding, marking a pivotal moment in the company’s validation roadmap.
- 2027 (Projected): Samay anticipates a decision on a requested $3 million grant to scale the device for clinical use and seeks a $3.5 million "Fast-Track" SBIR grant to pioneer predictive analytics for COPD exacerbations.
- 2028 (Projected): The company plans to launch its first commercial iteration in the Colombian market, followed by a strategic expansion into the United States. Future plans also include a home-monitoring version of the system.
Supporting Data and Scientific Rigor
The NIH funding is specifically allocated to three rigorous research phases designed to ensure the sensor’s clinical reliability across diverse patient populations.
- Variable Analysis: Researchers will study how the sensor’s signal changes based on its precise placement on the thorax and the variance in a patient’s subcutaneous adipose tissue (body fat), which can dampen acoustic signals.
- Environmental Calibration: The study will quantify the impact of external noise and the patient’s own voice on the acoustic data, ensuring the sensor remains accurate in a busy clinical environment.
- Comparative Clinical Study: A trial involving 75 participants will test whether a 90-second acoustic scan can match the accuracy of traditional spirometry.
To date, Samay has raised approximately $7 million in total funding, with $3.5 million coming from non-dilutive sources, including the National Science Foundation (NSF) and the NIH. The company holds 24 patents across 17 jurisdictions, with clinical validation already conducted on more than 450 patients.
Implications for the Future of Respiratory Care
The timing of Sylvee’s emergence aligns with a global shift in clinical guidelines. The 2026 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report—the gold standard for managing the condition—has for the first time included a dedicated chapter on the role of Artificial Intelligence and emerging technologies. This inclusion explicitly mentions the analysis of respiratory sounds as a viable alternative to traditional testing, placing Samay at the cutting edge of global medical standards.
The Transnational Business Model
Samay operates as a truly binational entity, maintaining a presence in both Silicon Valley and Colombia. With a core team of 25 professionals split between Medellín and Bogotá, the company leverages Colombian engineering talent while tapping into the venture capital and regulatory networks of the U.S. market.
"Receiving this award represents a validation of the work we have built over the years," Dr. Artunduaga noted. "The proposal was reviewed by independent scientists who evaluated the evidence, the rigor of our research, and the viability of the technology."
Conclusion: A New Standard for Diagnostics
By bringing high-tech diagnostic capabilities into a 90-second, non-invasive procedure, Samay is positioning itself to disrupt a market that has remained stagnant for decades. The company’s strategy—beginning with a commercial launch in Colombia before scaling into the U.S. and eventually moving into the home-monitoring space—reflects a measured, data-driven approach to global health.
As the world continues to grapple with the rising prevalence of chronic respiratory conditions, innovations like Sylvee offer a glimpse into a future where technology acts as an early warning system rather than a late-stage intervention. For Dr. Artunduaga and her team, the mission remains clear: to ensure that what happened to her grandmother does not become the reality for millions of others worldwide. Through the fusion of sound, data, and a commitment to accessible care, Samay is breathing new life into the field of pulmonary diagnostics.
